FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
DYNA-LOK ANTERIOR PLATING SYSTEM
K Number: K936307
·
Decision Aug 14, 1995
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
2
Review Days
721
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Basic Information
- Device Name
- DYNA-LOK ANTERIOR PLATING SYSTEM
- K Number
- K936307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Danek Group, Inc.
- Date Received
- August 23, 1993
- Decision Date
- August 14, 1995
- Product Code
- MNH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Danek Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934582 | GDLH VARIABLE ANGLE CONNECTOR | Jun 21, 1994 | Substantially Equivalent for Some Indications |